OUR VISION
Systems Vision
From the very beginning, the aspirational scientific goal of C-SOPS was reflected in our Systems Vision: to develop a model-predictive integrated framework for systematically designing materials, structures, and processes used to manufacture substance delivery systems. After some reorganization, the scientific thrusts focused on the main areas of scientific inquiry required to enable this vision: understanding materials, processing steps, product structure, and integrated systems behavior. Continuous manufacturing was selected as our main test bed because, as quasi-steady processes, continuous systems provide the best scenario for the development of predictive models and the creation of model assisted design, optimization, and control methodologies. Our second test bed, film manufacturing, is also a continuous technology, although the material behavior and the specific processing steps are radically different. Our third test bed was more challenging, requiring longer time to reach maturity, but also promising to enable a completely different wave of innovation: precision medicine.
After a decade of sustained efforts, the record shows that we have largely succeeded in realizing this vision.
The pharmaceutical community of practice has adopted our central approach, and our focus on particle science and technology and process engineering for integrated product and process development is now common practice. Essentially all of our main initiatives have, in one way or another, became part of a new reality in how pharmaceutical products and processes are developed. It is no longer necessary to argue that continuous manufacturing is conquering the pharmaceutical industry, since even a cursory Internet search makes this point abundantly clear.
It is also plainly obvious that C-SOPS has been a central player in enabling this revolution:
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The 2016 report by the Office of Science and Technology Policy (OSTP), which identifies Continuous Pharmaceutical Manufacturing as one of just five “Manufacturing Technologies of Emerging Priority”, lists C-SOPS as the first example of “selected federal investments”
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In May 2015, FDA invited C-SOPS to develop a draft of FDA’s future guidance on Continuous Manufacturing. The draft is largely completed and will be submitted to FDA before the reverse site visit.
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In July 2015, C-SOPS obtained our second AIR grant ($800,000), also in partnership with Janssen and involving all four core institutions, to commercialize modeling technology for continuous manufacturing
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In December 2015, FDA provided to C-SOPS its largest grant ever to a US university ($4,000,000) to support FDA in developing a scientific foundation for regulatory elements in continuous manufacturing
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FDA also provided C-SOPS a second grant, to NJIT, for $900,000, to develop an enhanced understanding of oral films manufacturing.
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BARDA identified Continuous Manufacturing as a key enabling technology for emerging threat response, and has initiated discussions with C-SOPS regarding large scale collaborations.
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In October of 2015, the FDA solicited proposals to establish “Continuous Manufacturing Platform Technologies”. The C-SOPS team developed a pre-proposal for $16,500,000, and submitted it on March 2016. On May 31, 2016, the FDA issued a written invitation to C-SOPS to submit a full proposal for the final round of funding for FY17.
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The United States Pharmacopeia, at FDA’s request, decided to develop a major area of operations in continuous manufacturing, and has formally requested C-SOPS assistance in selecting its path into this area, which will be initiated by a USP-sponsoring road-mapping workshop, to be held in Bethesda, Maryland, three days before our reverse site visit.
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NIST issued a NOI indicating an interest in NNMI applications focusing on Continuous Bio-manufacturing. Rutgers and NJIT responded by submitting a preliminary proposal involving also Purdue and UPR as well as eight other universities and many of the C-SOPS industrial partners. This pre-proposal has now been invited to participate as a full proposal in the final competition.
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Our partnership with Janssen Pharmaceuticals, now involving Rutgers, Purdue, and UPR, has obtained FDA approval for the jointly developed continuous manufacturing process for the drug Prezista. This is the first ever approval by FDA for a direct compression process, and also the first approved conversion from batch to continuous manufacturing.
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ERC research in engineered particles has led to a productive industry collaboration and project sponsorship, which led to a patented solvent-less coating process. This process, developed to mask the most challenging, unpleasant and bitter tasting pharmaceutical active ingredients, is also applicable to controlled release formulations. This has been subsequently licensed by Catalent Pharma Solutions.
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International collaborations and global training efforts are emerging from the establishment of the International Institute of Advanced Pharmaceutical Manufacturing supported by NSF-SAVI (US) and EPSRC (UK).
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As a result of these and other events and outcomes, dozens of companies are reaching out for C-SOPS assistance in initiating, or enlarging, their effort in continuous manufacturing and other areas.
Importantly, the conversion from Batch to Continuous Manufacturing has become a global phenomenon, triggering rapid progress in other areas as well. Multiple centers have emerged in Europe focusing on complementary efforts, including CMAC in the UK, RCPE in Austria, and other efforts in Ireland, Belgium, Finland, China, Argentina, and several others. All of these teams have reached out to C-SOPS for consultation and partnership and currently we have active collaborations with all of them. In parallel, in the last six months, C-SOPS has initiated collaborations in continuous manufacturing with companies in Europe and in China and has been approached for additional opportunities by additional companies, also in China, Peru, Japan, and Singapore.
In previous years, we reported how major conferences such as AIChE, AAPS, and ISPE had developed sections focusing on continuous manufacturing, pharmaceutical particle technology, pharmaceutical process modeling, and others. This trend has continued to expand significantly, and now there are conferences on these topics seemingly every month, not only in the US, but also in Europe and in Asia. It is not a productive use of space to list them, as there are simply too many of them taking place. C-SOPS no longer attempts to participate in all of them, since now there is a rapidly growing community of practice and we are fully integrated into it via collaborations.
Given these recent developments, we believe it is no longer necessary, or appropriate, to discuss “barriers to implementation of C-SOPS vision”, since, as mentioned, our vision is being implemented rapidly. Instead, we offer a list of “desirable future developments” which reflect our current thinking of where to focus our future efforts.